NCT02399839

Brief Summary

To evaluate the outcomes of pregnancy in women treated with lomitapide.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 23, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 26, 2015

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

December 16, 2022

Status Verified

December 1, 2022

Enrollment Period

8.2 years

First QC Date

March 23, 2015

Last Update Submit

December 14, 2022

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Pregnancy

    To evaluate the outcomes of pregnancy in women treated with lomitapide at any time within 30 days prior to first day of Last Menstrual Period (LMP) or during pregnancy. The outcomes of primary interest are major congenital anomalies.

    2 Years

Interventions

lomitapideDRUG

As prescribed by Physician.

Also known as: Juxtapid, Lojuxta

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant Females

You may qualify if:

  • Pregnant females exposed to lomitapide at any time within 30 days prior to first day of the LMP or during pregnancy.

You may not qualify if:

  • Patients who are unable or unwilling to provide written informed consent or assent are not eligible to participate in the PER.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinikum der Universität München

München, Bavaria, 80336, Germany

Location

MeSH Terms

Interventions

BMS201038

Study Officials

  • Sallyann O'Brien

    Amryt Pharmaceuticals

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
2 Years
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2015

First Posted

March 26, 2015

Study Start

October 1, 2014

Primary Completion

December 1, 2022

Study Completion

December 1, 2022

Last Updated

December 16, 2022

Record last verified: 2022-12

Locations

DE(1)